This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH. Participants who complete the treatment during Part A of the study and meet the inclusion criteria will have the option to enroll in Part B (open label) of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
380
Efimosfermin alfa (subcutaneous injection) will be administered.
Placebo (subcutaneous injection) will be administered.
GSK Investigational Site
Little Rock, Arkansas, United States
RECRUITINGGSK Investigational Site
Miami, Florida, United States
RECRUITINGGSK Investigational Site
Miami, Florida, United States
RECRUITINGGSK Investigational Site
Ocala, Florida, United States
RECRUITINGGSK Investigational Site
Springboro, Ohio, United States
RECRUITINGGSK Investigational Site
Westlake, Ohio, United States
RECRUITINGGSK Investigational Site
Austin, Texas, United States
RECRUITINGGSK Investigational Site
Dallas, Texas, United States
RECRUITINGGSK Investigational Site
Humble, Texas, United States
RECRUITINGGSK Investigational Site
San Antonio, Texas, United States
RECRUITING...and 2 more locations
Part A: Proportion of participants achieving improvement in liver fibrosis by >=1 stage and no worsening of MASH
Participants experiencing improvement in liver fibrosis of \>=1 stage (based on MASH Clinical Research Network (CRN) fibrosis score) and no worsening of MASH (defined as no increase in nonalcoholic fatty liver disease activity score for ballooning, inflammation, or steatosis). MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity.
Time frame: At Week 96
Part A: Proportion of participants achieving change from Baseline in vibration-controlled transient elastography (VCTE)- liver stiffness measurement (LSM) and in enhanced liver fibrosis (ELF) score
VCTE-LSM is a non-invasive test that uses vibration-controlled transient elastography to measure the stiffness of the liver in kilopascal (kPa). ELF score (scale of 6.7 to 11.3 with higher scores indicative of increased fibrosis) is a blood-based noninvasive test used as a prognostic marker for disease progression.
Time frame: Baseline (Day 1) and Week 96
Part A Change from Baseline in VCTE-LSM
VCTE-LSM is a non-invasive test that uses vibration-controlled transient elastography to measure the stiffness of the liver in kPa.
Time frame: Baseline (Day 1) and Week 96
Part A: Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) and TEAEs by severity
Time frame: Week 96
Part A: Proportion of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity
Time frame: Week 96
Part A: Proportion of participants with Grade 3 and Grade 4 laboratory abnormalities
Time frame: Week 96
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